Duns Number:338454995
Device Description: MIDDLE EAR ANALYZER.Clarinet Plus is a clinical middle ear analyzer, capable of performing MIDDLE EAR ANALYZER.Clarinet Plus is a clinical middle ear analyzer, capable of performing: tympanometry and acoustic reflex tests in sequence and automatically, acoustic reflex decay, acoustic reflex latency, Eustachian Tube Function (ETF) both for intact and perforated tympanic membrane, multi-frequency (with 678, 800 and 1000 Hz probe tones) and multi-component (Y, B and G) tympanometry.
Catalog Number
10542
Brand Name
CLARINET
Version/Model Number
CLARINET PLUS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PTO
Product Code Name
Tester, Auditory Impedance, Exempt
Public Device Record Key
ddb9d721-3fd8-4d2d-b5e6-e7f1f7bedf8f
Public Version Date
June 05, 2018
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |